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Supplement for Teething Infants Recalled Due to Poisonous Herbal Ingredient

By November 11, 2010July 18th, 2019Dangerous Drugs

The last thing a parent with a teething baby wants is to cause their baby to suffer more pain. Unfortunately, according to a recent recall announced by the U.S. Food and Drug Administration, some parents may have inadvertently done just that. Hyland’s Teething Tablets, a homeopathic product containing belladonna, was recalled after the FDA received reports of serious adverse events in babies who took the product. Belladonna, also known as deadly nightshade, is one of the most well known poisonous plants in the Western hemisphere. As a defective drug lawyer, I applaud the FDA for moving quickly and hope that no more children are harmed.
According to the manufacturer, Hyland’s Teething Tablets are meant to provide homeopathic relief for teething babies. The product is sold as an over-the-counter dietary supplement in grocery and drug stores. The recall notice suggests, but does not outright say, that the FDA has already identified manufacturing problems responsible for the adverse event reports it’s received. Those reports suggest that the infants who got sick suffered a toxic overdose of belladonna. The manufacturer has recalled the tablets and parents are advised to stop using them immediately, and to discard any tablets that they still have. The FDA advises consumers to contact a health care professional if their child takes the tablets and then experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation.
As a defective medication lawyer, I think this is a good reminder that patients are not well protected from “dietary supplements” marketed as medical cures. Even though the FDA does not treat homeopathic medications like Hyland’s Teething Tablets as drugs, the manufacturer instructs parents to treat it as any other medication, in consultation with a licensed health care practitioner. While the manufacturer says it’s “virtually impossible” to overdose on the product, the FDA’s findings suggest otherwise. The tablets are manufactured to contain a small amount of highly toxic belladonna — just two to five berries from the plant can kill a child. That means the amount of the belladonna should be carefully controlled — yet FDA laboratory analysis has shown that the amount of belladonna varies widely from tablet to tablet. In addition, the containers in which the tablets are sold do not have child-proof caps, so children have been able to open the containers and consume more of the tablets than recommended.

Like all companies that market their products directly to the public, drug manufacturers are required by law to warn consumers about the risks of their products. Speaking as a dangerous drug liability attorney, if the manufacturer knows about risks and chooses not to warn the public, consumers who are harmed by these drugs have the right to recover compensation from the drug manufacturer. That means they can sue to have their medical costs paid for, as well as compensation for pain and suffering, lost income, and lost quality of life. Relatives of someone who was killed by a defective drug may also hold the drug manufacturer responsible for the personal and financial losses caused by the death. Carey, Danis & Lowe helps people who have been hurt by dangerous drugs. If you or someone you love has been seriously harmed by a prescription or over-the-counter medication, our attorneys can help.
If you have been hurt by a defective medication, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.